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Sep 25, 2024
Regulatory Affairs
New GMP Compliance Requirements for Drug Substance Manufacturers for regulatory submission in Singapore
Previously, drug substance manufacturers submitting applications for new drugs, generic drugs, or minor variations involving the introduction or change of a drug substance (DS) manufacturer were not required to provide GMP evidence. However, starting from October 1st, it is essential to note that GMP compliance evidence will be mandatory for these submissions in Singapore. This regulatory change aligns the quality requirements for drug substance manufacturers with those for drug product manufacturers, ensuring a consistent standard of quality across the industry.
Required Evidence for GMP Compliance
To comply with the updated regulations, drug substance manufacturers must submit the following acceptable forms of GMP compliance evidence:
- GMP Certificate: Issued by PIC/S (Pharmaceutical Inspection Co-operation Scheme) member authorities for the specific drug substance.
- GMP Inspection Report: This report must detail the GMP inspection, including the drug substance of interest, along with a close-out letter from PIC/S authorities that do not issue certificates.
- API Registration Certificate: This certificate confirms that the Active Pharmaceutical Ingredient (API) is listed on EudraGMDP (European Database on Good Manufacturing Practices).
- Certificate of a Pharmaceutical Product (CPP): This must be issued by the US FDA for the API.
- Manufacturing License: A license from a PIC/S authority covering the drug substance of interest.
Implications of the New Requirement
As these new regulations take effect, there will be several implications for products already registered in Singapore or those planning to submit applications:
- For new drug and new generic drug applications scheduled for submission in Q3-Q4, manufacturers will need to reassess their compliance with the new requirements.
- Existing products that involve a change of manufacturing site will require a reassessment of the supplier’s conformity to the GMP standards mandated in Singapore, which may impact the overall product lifecycle.
Important points to note:
- Products that were approved or submitted before October 1st will not be affected by this new requirement.
- DS manufacturer who has a valid CEP issued for their DS complying to the monograph of European Pharmacopeia , the submission of the GMP evidence is optional.
Ensuring GMP compliance is more than just a regulatory obligation; it represents a commitment to quality and patient safety. By preparing the necessary documentation and adhering to GMP standards, manufacturers can streamline their approval processes and enhance their credibility within the industry.
If you require assistance in evaluating your dossier prior to submission or have any questions regarding GMP compliance, please don’t hesitate to reach out. We are here to help you navigate these requirements effectively.
If you have any specific regulatory questions pertaining to entering the Singapore market or require assistance with pharma regulatory services and medical product registration, feel free to reach out. Your success in the pharmaceutical industry starts with us!